In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD, PhD, a medical oncologist at Seattle Cancer Care Alliance, Associate Professor at the University of Washington, and Associate Member of Fred Hutchinson Cancer Research Center.
Petros Grivas, MD, PhD
Researchers presented the interim results at the ASCO20 Virtual Scientific Program1 and published the final analysis in TheNew England Journal of Medicine.2 Additional analyses from the trial were presented at the European Society for Medical Oncology Virtual Congress 2020.3-5 Based on the trial results, the U.S. Food and Drug Administration (FDA) approved avelumab for certain patients with advanced urothelial carcinoma in June 2020.
JAVELIN Trial Findings
Urothelial carcinoma most commonly manifests as bladder cancer but can also affect other parts of the urinary tract. The data from this trial show that patients who received the immune-boosting drug after chemotherapy lived longer than those who did not. The median overall survival was about 21 months in those who received the drug vs about 14 months in those who did not.
“These data, in my humble opinion, should change the way we treat this disease. It’s practice-changing,” Dr. Grivas noted. “Because instead of waiting until disease progression after the completion of front-line chemotherapy, with the new data, if there’s no disease progression, we’re going to hit it back to back with immunotherapy after the completion of chemotherapy.… And this seems to be prolonging life, based on the data so far,” he added.
Implications for the Future
“[Metastatic cancer] is a challenging condition, and usually there is no cure for it. But over the past 5 to 6 years, we have seen data on immunotherapy that have actually prolonged life compared with what we had before that, just chemotherapy alone,” Dr. Grivas said. “And just for context, I can say there are other drugs that are being approved by the FDA—antibody-drug conjugates, targeted therapies—that all together, I think, can move the needle forward.”
Dr. Grivas observed that it has been difficult to conduct a clinical trial that actually prolongs overall survival. “So, despite the very promising role of immunotherapy, only two phase III clinical trials [in this disease setting] have led to statistically significant—with statistical rigor—improvement in overall survival, as a primary endpoint,” he said.
DISCLOSURE: Pfizer funded this study as part of an alliance between Pfizer and Merck KGaA, Darmstadt, Germany. Dr. Grivas has served as an advisor to and has received institutional research funding from Pfizer.
1. Powles T, et al: Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line chemotherapy in advanced urothelial carcinoma. ASCO20 Virtual Scientific Program. Abstract LBA1.
2. Powles T, et al: Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med 383:1218-1230, 2020.
3. Grivas P, et al: Avelumab first-line (1L) maintenance + best supportive care (BSC) vs BSC alone with 1L chemotherapy for advanced urothelial carcinoma. ESMO Virtual Congress 2020. Abstract 704MO. Presented September 18, 2020.
4. Sridhar S, et al: Avelumab first-line maintenance + best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma. ESMO Virtual Congress 2020. Abstract 699O. Presented September 19, 2020.
5. Powles TB, et al: Patient-reported outcomes from JAVELIN Bladder 100. ESMO Virtual Congress 2020. Abstract 745P.